FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1071280
·
Received July 7, 2008
Report
- Report Number
- 1644487-2008-01553
- Event Type
- Injury
- Date Received
- July 7, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 30, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A PT'S VNS GENERATOR WAS " LOOSE AND MOVES IN CHEST" AND THAT "IF SHE TURNS ON HER SIDE IT SLIPS OVER." IT WAS REPORTED THAT THE PT HAD BEEN IN A CAR ACCIDENT, WHICH WAS BELIEVED TO BE THE CAUSE OF THE EVENTS. IT WAS ALSO REPORTED THAT DIAGNOSTIC TESTS WERE OK. THE PT UNDERWENT REVISION SURGERY DUE TO THE EVENT, AND THE SURGEON ELECTED TO REPLACE THE GENERATOR DURING THE SURGERY AS THE EXISTING GENERATOR HAD BEEN IMPLANTED FOR OVER TWO YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 13755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |